Heart Failure Clinical Trial

HF2 Registry – Hemodynamic Frontiers in Heart Failure Registry

Summary

The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research.

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Full Description

Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).

Exclusion Criteria:

Patients less than 18 years of age.
Pregnant women at the scheduled time of PA pressure sensor implant.
Patients unable or unwilling to have continuity of care in the heart failure clinic.

Study is for people with:

Heart Failure

Estimated Enrollment:

2000

Study ID:

NCT06425848

Recruitment Status:

Recruiting

Sponsor:

University of Kansas Medical Center

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There are 12 Locations for this study

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Scripps Health
La Jolla California, 92037, United States More Info
Timothy Jordan, MD
Contact
Thomas Heywood, MD
Principal Investigator
Indiana University
Bloomington Indiana, 47401, United States More Info
Maya Guglin, MD
Contact
Maya Guglin, MD
Principal Investigator
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Kartik Munshi, MPH
Contact
[email protected]
Hirak Shah, MD
Principal Investigator
Fairview Health
Maplewood Minnesota, 55109, United States More Info
Terrie-Ann Benjamin, MD
Contact
Terrie-Ann Benjamin, MD
Principal Investigator
Minneapolis Heart Institute Foundation/ Allina Health
Minneapolis Minnesota, 55407, United States More Info
Sarah Schwager, RN
Contact
Mosi Bennett, MD
Principal Investigator
Saint Luke's Health System
Kansas City Missouri, 64131, United States More Info
Timothy Fendler, MD
Contact
Timothy Fendler, MD
Principal Investigator
University of North Carolina/ Rex Hospital, Inc.
Raleigh North Carolina, 27607, United States More Info
Elizabeth Volz, MD
Contact
Elizabeth Volz, MS
Principal Investigator
Providence Heart Institute
Portland Oregon, 97225, United States More Info
Christy Lenhart, RN
Contact
Jacob Abraham, MD
Principal Investigator
Prisma Health
Columbia South Carolina, 29203, United States More Info
Suzanne Amaker
Contact
Patrick McCann, MD
Principal Investigator
Sanford Health
Sioux Falls South Dakota, 57104, United States More Info
Orvaar Jonsson, MD
Contact
Orvaar Jonsson, MD
Principal Investigator
Austin Heart
Austin Texas, 78756, United States More Info
Kunjan Bhatt, MS
Contact
Kunjan Bhatt, MD
Principal Investigator
Houston Methodist DeBakey Heart and Vascular Center
Houston Texas, 77030, United States More Info
Saba Khan
Contact
Ashrith Guha, MD
Principal Investigator
Arvind Bhimaraj, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

2000

Study ID:

NCT06425848

Recruitment Status:

Recruiting

Sponsor:


University of Kansas Medical Center

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